Adverse Reactions from Clinical Trials: See Table 2.
Click on icon to see table/diagram/imagePost-marketing Adverse Reactions: The following additional adverse reactions have been reported in the postmarketing experience, listed by MedDRA System Organ Class (SOC), then by Preferred Term (PT) in order of severity.
GASTROINTESTINAL DISORDERS: Diarrhea.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS: Pruritus.
IMMUNE SYSTEM DISORDERS: Hypersensitivity with the manifestations of rash and dyspnea.
INVESTIGATIONS: International normalized ratio decreased.
Class/Other Reactions: Blood and lymphatic system disorders: Thrombocytopenia.
Hepatobiliary disorders: Parenteral Nutrition associated liver disease (including Hepatic failure, Hepatic cirrhosis, Hepatic fibrosis, Cholestasis, Hepatic steatosis, Cholecystitis, Cholelithiasis).
Injury, poisoning and procedural complications: Fat overload syndrome.
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